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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NamenAbCyte Anti-AAVRh74var HB-FE Assay
Classification Nameassays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors
Generic Nameassays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors
Applicant
LabCorp Drug Development
100 perimeter park drive, ste c
morrisville, NC 27560
HDE NumberH230005
Date Received07/26/2023
Decision Date04/25/2024
Product Code
QWQ[ Registered Establishments with QWQ ]
Advisory Committee Hematology
Clinical Trials NCT03861273
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for nabcyte anti-aavrh74var hb-fe assay: the nabcyte anti-aavrh74var hb-fe assay for beqvez™ (fidanacogene elaparvovec) eligibility in moderate to severe hemophilia b, or nabcyte anti-aavrh74var hb-fe assay, is a cell-based qualitative in vitro companion diagnostic device intended for the detection of neutralizing antibodies to the aavrh74var capsid in serum specimens from adult patients previously diagnosed with moderate to severe hemophilia b to determine eligibility for treatment with the hemophilia b gene therapy, beqvez (fidanacogene elaparvovec). Patients who test positive for neutralizing antibodies to the aavrh74var capsid are not eligible for treatment with beqvez (fidanacogene elaparvovec). Patients who test negative for neutralizing antibodies to the aavrh74var capsid are eligible for treatment with beqvez (fidanacogene elaparvovec). This diagnostic device is a single-site assay for professional use only and is to be performed only at labcorp-monogram biosciences by trained and qualified laboratory personnel.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
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